Zynquista
Country: Unjoni Ewropea
Lingwa: Ingliż
Sors: EMA (European Medicines Agency)
Fuljett ta 'informazzjoni
(PIL)
16-08-2022
Karatteristiċi tal-prodott
(SPC)
16-08-2022
Rapport ta 'Valutazzjoni Pubblika
(PAR)
16-08-2022
Ingredjent attiv:
Sotagliflozin
Disponibbli minn:
Guidehouse Germany GmbH
Kodiċi ATC:
A10
INN (Isem Internazzjonali):
sotagliflozin
Grupp terapewtiku:
Drugs used in diabetes
Żona terapewtika:
Diabetes Mellitus, Type 1
Indikazzjonijiet terapewtiċi:
Zynquista is indicated as an adjunct to insulin therapy to improve glycaemic control in adults with type 1 diabetes mellitus with a Body Mass Index (BMI) ≥ 27 kg/m2, who have failed to achieve adequate glycaemic control despite optimal insulin therapy.,
Sommarju tal-prodott:
Revision: 3
L-istatus ta 'awtorizzazzjoni:
Withdrawn
Data ta 'l-awtorizzazzjoni:
2019-04-26
Fuljett ta 'informazzjoni
39
B. PACKAGE LEAFLET
Medicinal Product no longer authorised
40
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
ZYNQUISTA 200 MG FILM-COATED TABLETS
sotagliflozin
This medicine is subject to additional monitoring. This will allow
quick identification of new
safety information. You can help by reporting any side effects you may
get. See the end of section 4
for how to report side effects.
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS
MEDICINE BECAUSE IT CONTAINS
IMPORTANT INFORMATION FOR YOU.
-
Keep this leaflet. You may need to read it again.
-
If you have any further questions, ask your doctor, pharmacist or
nurse.
-
This medicine has been prescribed for you only. Do not pass it on to
others. It may harm them,
even if their signs of illness are the same as yours.
-
If you get any side effects, talk to your doctor, pharmacist or nurse.
This includes any possible
side effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1.
What Zynquista is and what it is used for
2.
What you need to know before you take Zynquista
3.
How to take Zynquista
4.
Possible side effects
5.
How to store Zynquista
6.
Contents of the pack and other information
1.
WHAT ZYNQUISTA IS AND WHAT IT IS USED FOR
Zynquista contains the active substance sotagliflozin, a medicine
which lowers blood glucose (blood
sugar) levels. Sotagliflozin works by slowing and reducing the
absorption of glucose from food, and
by increasing the amount of glucose that is passed out in urine.
Together these actions help to lower
the increased amount of glucose in the blood that occurs in patients
with diabetes.
Zynquista is used as an addition to insulin treatment in adults with
type 1 diabetes with a body mass
index (BMI) greater than or equal to 27. BMI is a measure of your
weight in relation to your
height.Type 1 diabetes is a disease where your body’s immune system
destroys the insulin-producing
cells in the pancreas and the body produces little to no insulin, the
hormone that normally controls the
level of your blood sugar.
I
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Karatteristiċi tal-prodott
1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
Medicinal Product no longer authorised
2
This medicinal product is subject to additional monitoring. This will
allow quick identification of
new safety information. Healthcare professionals are asked to report
any suspected adverse reactions.
See section 4.8 for how to report adverse reactions.
1.
NAME OF THE MEDICINAL PRODUCT
Zynquista 200 mg film-coated tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 200 mg sotagliflozin.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Film-coated tablet (tablet).
Oval, blue, film-coated tablet printed with “2456” on one side in
black ink (tablet length: 14.2 mm,
tablet width: 8.7 mm).
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Zynquista is indicated as an adjunct to insulin therapy to improve
glycaemic control in adults with
type 1 diabetes mellitus with a Body Mass Index (BMI) ≥ 27 kg/m
2
, who have failed to achieve
adequate glycaemic control despite optimal insulin therapy.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Therapy with Zynquista should be initiated and supervised by a
physician experienced in the
management of type 1 diabetes mellitus.
Posology
The recommended dose is 200 mg sotagliflozin once daily before the
first meal of the day. After at
least three months, if additional glycaemic control is needed, in
patients tolerating sotagliflozin
200 mg, the dose may be increased to 400 mg once daily.
Before initiating treatment with sotagliflozin 200 mg and before
increasing dose to sotagliflozin 400
mg:
-
Risk factors for diabetic ketoacidosis (DKA) should be assessed and
ketone levels should be
evaluated as normal. If ketones are elevated (blood
beta-hydroxybutyrate (BHB) reading is
greater than 0.6 mmol/L or urine ketones one plus (+)) treatment with
sotagliflozin should not
be initiated nor the dose should be increased to sotagliflozin 400 mg
until the ketone levels are
normal (see sections 4.4).
-
It is recommended that patients obtain several baseline blood
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